EASAC
Realising European potential in synthetic biology | December 2010 | 23
The initial discussions that led to this EASAC project
identifi ed three main objectives for the report, which are
as follows.
(1) Clarifying scientifi c strengths and weaknesses,
with the aim of developing critical mass in Europe,
across fi elds and across R&D communities—noting
where there is scope to increase resources and
standardise methodologies, and where there are
realistic prospects for innovation. Scalability – fi lling
the current translational gap between basic research
studies and industrial applications – may be a
particularly important element in building the critical
mass.
(2) Raising awareness of the opportunities and
challenges—both within the scientifi c community
and with the public. It is important to evaluate what
could be the possible benefi ts as well as the safety
and ethical concerns to provide balanced information
to policy-makers.
(3) Exploring how science can inform policy
development in governance of the technologies and
promotion of EU competitiveness.
7.1
Previous recommendations at Member
State level
The publication from the Royal Netherlands Academy and
the German Statement make some recommendations for
national attention that provide a useful foundation for
considering what then should be attended to at the EU
level:
(1)
Sustained investment in basic research is vital—
recognising that most application-oriented
programmes are still at the design stage, there must
be increasing public investment in synthetic biology,
possibly in connection with existing related initiatives
in genomics, nanomedicine and systems biology and
the effi cient use of available infrastructure.
(2) Investing in interdisciplinary research to generate
synergies is also essential—recognising that this
also has implications for education and training, for
example in Master’s level degree programmes.
(3) Commercial exploitation depends not only on
excellent research but also on the appropriate
strategic, legal and societal framework and on
mechanisms to ensure fast knowledge transfer to
industry—this requires patent protection (under
same conditions as applied previously to recombinant
gene products and gene fragments). There must also
be expansion of research into, and communication
about, the social aspects of synthetic biology.
(4) The existing legislation for biosafety and biosecurity
is adequate—but developments are diverse and
dynamic so continuing monitoring of advances in
the science and technology is needed, together with
establishing clear criteria for assessing and managing
risks in contained use and deliberate release, for both
human and environmental protection. The voluntarily
agreed systems (self-regulation) to reduce risk of
misuse are important; if additional rules are needed
these must be subject to international agreement.
(5) Consideration of ethical issues must continue—
ensuring that Academy scholarship helps to clarify
and focus the discussion of synthetic biology.
7.2 EASAC recommendations for the EU
Drawing on this analysis at the national level and
the EASAC Working Group deliberations, key issues
for Europe in providing the multi-national strategic
framework for supporting synthetic biology are outlined
in Box 2.
However, to what extent should a specifi c policy focus on
synthetic biology be developed? It is not yet clear if such
a policy focus would advance the fi eld or, alternatively,
would risk creating additional barriers by making new
distinctions from other fi elds. In considering whether to
develop a specifi c strategy for synthetic biology, public
policy-makers, at national and EU level, need also to
consider the following:
(1) their role in stimulating synthetic biology research
activity – relative to other funders and other funding
priorities;
(2) their responsibilities for policy issues associated with
security, ethics and public dialogue—clarifying who
else shares the responsibilities;
(3) the desired balance between national priorities and
international co-ordination.
The EGE has urged the European Commission to propose
and implement a robust governance framework and to
raise the issues for governance in relevant global fora.
However, there is a countervailing view, expressed in some
of the discussion in the academies’ publications, that
seeking new governance mechanisms is premature. As
yet, there is no consensus on whether synthetic biology
will be a transformational technology and, if so, whether
it can or cannot be accommodated within the current
7 Summary of issues and recommendations
24
| December 2010 | Realising European potential in synthetic biology
EASAC
and interdisciplinary research accompanied by review of
risk management procedures that will be consistent with
many of the recommendations made by EGE, but do not
require policy-makers to judge now whether synthetic
biology is ethically different or conceptually distinct from
other scientifi c fi elds.
In developing our recommendations, EASAC aims to
address three goals: (1) to confi rm what more needs to be
done in those Member States who are already most active
in synthetic biology; (2) to identify options for building
capacity in other Member States; and (3) to establish
the policy options for a coherent strategy at the EU level
covering research, education, innovation and regulation.
(1) Research capacity building
There is a signifi cant agenda for what might be advised
about extra investment in synthetic biology by Member
States and the European Commission (DG Research),
while avoiding misuse of research:
• Core disciplines. In some areas there is a need
to strengthen the traditional disciplines such as
physiology and microbiology. The case can also be
made for highlighting more explicitly the key role of
the chemistry–biology interface in advancing synthetic
biology. In some of these disciplines, Europe remains
ahead of the USA and Asia and there is enormous
potential to enhance European competitiveness.
Moreover, progress in synthetic biology depends not
only on input from the laboratory-based sciences but
also on the social sciences and humanities. Therefore,
academic funding bodies must recognise the need for
broadly based support.
• Centres of Excellence. One option is to establish
integrative Centres of Excellence in synthetic
biology—where research is already internationally
competitive in chemistry, biology, medicine,
engineering and the other relevant disciplines. These
could help to foster interdisciplinary perspectives
by tackling the current obstacles to bridging the
disciplines and attracting new support by research
funders. Centres of Excellence can also serve as a
focal point to seek collaboration with industry and
others involved in delivering the products and services
resulting from synthetic biology.
• European Commission funding. A good case
can be made for new European funding to bring
together synthetic biology research from the
smaller laboratories across the EU, where there
is already demonstrable excellence. In addition,
synthetic biology can capitalise on other areas of
research already strongly funded by the European
Commission, such as epigenetics and epigenomics.
Synthetic biology approaches may well be fruitful,
regulatory framework. It is also important to acknowledge
that safety can be engineered into the applications of
synthetic biology. Nonetheless, the EU must continue
to review science and technology developments and be
prepared to act if voluntary codes or current regulatory
procedures appear insuffi cient. The member academies
of EASAC have an important continuing role in alerting
EU and national policy-makers to such developments.
Furthermore, it seems entirely reasonable to develop
practical recommendations on the need to invest in basic
Box 2 Synthetic biology: what issues do
policy-makers at the EU level need to
consider?
• Research capacity. Where are the priority areas
for the EU/Member States to compete given that
the USA established an early lead in some key
research directions? Should funding be invested
in new dedicated synthetic biology initiatives or
aligned with other programmes in genomics,
nanotechnology etc?
• Higher education. How will the new
interdisciplinary skills and lifelong learning
be delivered to address the urgent needs for
training the next generation of scientists?
• Protection of innovation. What can be patented
and can the open exchange of pre-competitive
information be maintained? Is there anything
special about the IPR issues for synthetic
biology?
• Public engagement. How can dialogue with the
scientifi c community be encouraged, avoiding
hyperbole and communicating based on sound
science? What lessons have been learned from
previous diffi culties in engaging on social and
ethical issues in emerging technologies?
• Biosafety. What are the new issues for human
and environmental protection and what are
the options for managing containment in
laboratory and production facilities and for
deliberate release? What can be expected
from self-regulation? Can legislation be
introduced without reducing the fl exibility to
encourage future science and manage future
developments?
• Biosecurity. How to appraise the potential for
abuse at the State, organisational or individual
level at a time when the progressive deskilling of
biotechnology facilitates its wider application? In
addition to the issues for controlling production,
there are considerations relating to the adequacy
of surveillance and public health infrastructure
to respond to deliberate attacks and accidents.
• Global governance and regulation. How best
should the EU contribute to the international
framework for policy development?